FDA Grants Fast Track Designation to MoonLake’s Sonelokimab for Palmoplantar Pustulosis

Reuters02-02 21:00

FDA Grants <a href="https://laohu8.com/S/FTRK">Fast Track</a> Designation to MoonLake’s Sonelokimab for Palmoplantar Pustulosis

MoonLake Immunotherapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sonelokimab (SLK) for the treatment of moderate-to-severe palmoplantar pustulosis (PPP). The designation is supported by positive Phase 2 LEDA trial results and is expected to facilitate more frequent interactions with the FDA, earlier and more frequent written communication, and eligibility for Accelerated Approval, Priority Review, and Rolling Review, if applicable. The company plans to submit a Biologic License Application (BLA) for SLK in hidradenitis suppurativa (HS) in the second half of 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Moonlake Immunotherapeutics published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW1001162492-en) on February 02, 2026, and is solely responsible for the information contained therein.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/2608861869?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-02-02 21:00","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2608861869","market":"nz","top_or_hot":-1,"title":"FDA Grants Fast Track Designation to MoonLake’s Sonelokimab for Palmoplantar Pustulosis","media":"Reuters","content":"<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      FDA Grants <a href=\"https://laohu8.com/S/FTRK\">Fast Track</a> Designation to MoonLake’s Sonelokimab for Palmoplantar Pustulosis\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        <a href=\"https://laohu8.com/S/MLTX\">MoonLake Immunotherapeutics</a> announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sonelokimab (SLK) for the treatment of moderate-to-severe palmoplantar pustulosis (PPP). The designation is supported by positive Phase 2 LEDA trial results and is expected to facilitate more frequent interactions with the FDA, earlier and more frequent written communication, and eligibility for Accelerated Approval, Priority Review, and Rolling Review, if applicable. The company plans to submit a Biologic License Application (BLA) for SLK in hidradenitis suppurativa (HS) in the second half of 2026.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Moonlake Immunotherapeutics published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW1001162492-en) on February 02, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>","source":null,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>FDA Grants Fast Track Designation to MoonLake’s Sonelokimab for Palmoplantar Pustulosis</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nFDA Grants Fast Track Designation to MoonLake’s Sonelokimab for Palmoplantar Pustulosis\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time\">2026-02-02 21:00</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      FDA Grants <a href=\"https://laohu8.com/S/FTRK\">Fast Track</a> Designation to MoonLake’s Sonelokimab for Palmoplantar Pustulosis\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        <a href=\"https://laohu8.com/S/MLTX\">MoonLake Immunotherapeutics</a> announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sonelokimab (SLK) for the treatment of moderate-to-severe palmoplantar pustulosis (PPP). The designation is supported by positive Phase 2 LEDA trial results and is expected to facilitate more frequent interactions with the FDA, earlier and more frequent written communication, and eligibility for Accelerated Approval, Priority Review, and Rolling Review, if applicable. The company plans to submit a Biologic License Application (BLA) for SLK in hidradenitis suppurativa (HS) in the second half of 2026.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Moonlake Immunotherapeutics published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW1001162492-en) on February 02, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4585","symbol_name":"ETF&股票定投概念","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260202:nNDL4DtmKY:1","article_id":"2608861869","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2608861869","pubTimestamp":1770037214,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"MoonLake Immunotherapeutics announced that the U.S. Food and Drug Administration  has granted Fast Track designation to sonelokimab  for the treatment of moderate-to-severe palmoplantar pustulosis . The designation is supported by positive Phase 2 LEDA trial results and is expected to facilitate more frequent interactions with the FDA, earlier and more frequent written communication, and eligibility for Accelerated Approval, Priority Review, and Rolling Review, if applicable. The company plans to submit a Biologic License Application  for SLK in hidradenitis suppurativa  in the second half of 2026.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Moonlake Immunotherapeutics published the original content used to generate this news brief ","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4585":"ETF&股票定投概念","MLTX":"MoonLake Immunotherapeutics","BK4112":"金融交易所和数据","SG9999014021.USD":"UNITED GLOBAL DURABLE EQUITIES (USDHDG) ACC","LU2210150020.SGD":"Natixis Thematics Subscription Economy R/A SGD","SG9999014005.SGD":"United Global Durable Equities Fund Acc SGD","IE00BGHQF748.EUR":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (EUR) ACC","BK4139":"生物科技","IE00B3QW5Z07.USD":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (USD) ACC","SG9999014013.SGD":"United Global Durable Equities Fund Dis SGD","IE00B64PRP62.GBP":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (GBP) ACC","LU0314104364.USD":"MANULIFE GF AMERICAN GROWTH \"AA\" (USD) INC","NDAQ":"纳斯达克OMX交易所","LU2210149790.SGD":"Natixis Thematics Subscription Economy R/A SGD-H","SG9999014039.USD":"UNITED GLOBAL DURABLE EQUITIES (USDHDG) INC","IE00BKPKM429.USD":"NEUBERGER BERMAN GLOBAL SUSTAINABLE EQUITY \"A\" (USD) ACC","BK4588":"碎股","LU2095319765.USD":"Natixis Thematics Subscription Economy R/A USD"},"translate_title":"FDA授予MoonLake的Sonelokimab治疗掌跖脓疱病的快速通道资格","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"MLTX":0.9,"NDAQ":0.9},"content_text":"FDA Grants Fast Track Designation to MoonLake’s Sonelokimab for Palmoplantar Pustulosis\n    \n\nMoonLake Immunotherapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sonelokimab (SLK) for the treatment of moderate-to-severe palmoplantar pustulosis (PPP). The designation is supported by positive Phase 2 LEDA trial results and is expected to facilitate more frequent interactions with the FDA, earlier and more frequent written communication, and eligibility for Accelerated Approval, Priority Review, and Rolling Review, if applicable. The company plans to submit a Biologic License Application (BLA) for SLK in hidradenitis suppurativa (HS) in the second half of 2026.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Moonlake Immunotherapeutics published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW1001162492-en) on February 02, 2026, and is solely responsible for the information contained therein.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"tenantId":"TBGLOBAL","deviceId":"web-server-community-laohu8-v3","version":"4.36.2","shortVersion":"4.36.2","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2608861869","isCrawlerRequest":true}